The following data is part of a premarket notification filed by Electro Medical Systems Sa with the FDA for Ems Air-flow Handy 2 Dental Handpiece.
| Device ID | K022119 |
| 510k Number | K022119 |
| Device Name: | EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | ELECTRO MEDICAL SYSTEMS SA 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Mary Mcnamara-cullinane |
| Correspondent | Mary Mcnamara-cullinane ELECTRO MEDICAL SYSTEMS SA 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-01 |
| Decision Date | 2002-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613353063719 | K022119 | 000 |
| 07613353192020 | K022119 | 000 |
| 07613353195564 | K022119 | 000 |
| 07613353196202 | K022119 | 000 |
| 07613353130404 | K022119 | 000 |
| 07613353179151 | K022119 | 000 |
| 07613353181468 | K022119 | 000 |
| 07613353184353 | K022119 | 000 |
| 07613353185350 | K022119 | 000 |
| 07613353063559 | K022119 | 000 |
| 07613353063580 | K022119 | 000 |
| 07613353063696 | K022119 | 000 |
| 07613353063702 | K022119 | 000 |
| 07613353223939 | K022119 | 000 |